Airway Gas Option N-CAiO recall
Airway Gas Option N-CAiO
Why was Airway Gas Option N-CAiO recalled?
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Mfg. Lot or Serial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
- Product
- Airway Gas Option N-CAiO
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 12 units
- Distribution
- US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom
- Recall date
- January 22, 2020
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)